FDA Label for Childrens Pain Relief Oral Suspension
View Indications, Usage & Precautions
Childrens Pain Relief Oral Suspension Product Label
The following document was submitted to the FDA by the labeler of this product Pharmacy Value Alliance, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
Drug Facts
Otc - Active Ingredient
Active ingredient (in each 5 mL =1 teaspoonful)
Acetaminophen 160 mg
Otc - Purpose
Purpose
Pain reliever/fever reducer
Indications & Usage
Uses temporarily. reduces fever
■ relieves minor aches and pains due to:
■ the common cold ■ flu. headache. sore throat
■ toothache
Warnings
Warnings
liver warning
This product contains acetaminophen. Severe liver
damage may occur if your child takes: ■ more than 5
doses in 24 hours, which is the maximum daily amount
■ with other drugs containing acetaminophen
Allergy alert: acetaminophen may cause severe skin
reactions. Symptoms may include: ■ skin reddening
■ blisters ■ rash
If a skin reaction occurs, stop use and seek medical
help right away.
Sore throat warning
If sore throat is severe, persists for more than 2 days,
is accompanied or followed by fever, headache, rash,
nausea or vomiting, consult a doctor promptly.
Otc - Do Not Use
Do not use
■ with any other drug containing acetaminophen
(prescription or nonprescription). If you are not sure
whether a drug contains acetaminophen, ask a doctor
or pharmacist.
■ if your child is allergic to acetaminophen or any of
the inactive ingredients in this product.
Otc - Ask Doctor
Ask a doctor before use if your child has liver disease
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if your child
is taking the blood thinning drug warfarin.
Otc - When Using
When using this product do not exceed
recommended dose (see overdose warning)
Otc - Stop Use
Stop use and ask a doctor if
■ pain gets worse or lasts more than 5 days ■ fever
gets worse or lasts more than 3 days. new
symptoms occur. redness or swelling is present
These could be signs of aserious condition.
Keep Out Of Reach Of Children.
Keep out of reach of children.
Overdosage
Overdose warning
Taking more than the recommended dose (overdose)
may cause liver damage. In case of overdose, get
medical help or contact a Poison Control Center right
away. (1-800-222-1222) Quick medical attention
is critical for adults as well as for children even if you
do not notice any signs or symptoms.
Dosage & Administration
Directions
■ this product does not contain directions or
complete warnings for adult use.
■ shake well before using
■ mL = milliliter; tsp = teaspoonful
■ find right dose on chart below. If possible, use
weight to dose; otherwise, use age.
■ if needed, repeat dose every 4 hours while
symptoms last
■ do not give more than 5 times in 24 hours
■ do not give for more than 5 days unless directed
by a doctor.
Weight (Ib) Age (yr) Dose (mL or tsp)*
under 24 under 2 years ask a doctor
24-35 2-3 years 5 mL (1 tsp)
36-47 4-5 years 7.5 mL (1½ tsp)
48-59 6-8 years 10 mL (2 tsp)
60-71 9-10 year 12.5 mL (2½ tsp)
72-95 11 year 15 mL (3 tsp)
*or as directed by a doctor
Attention: use only enclosed dosing cup specifically
designed for use with this product. Do not use any
other dosing device.
Other Safety Information
Inactive ingredients anhydrous citric acid,
butylparaben, D&C Red # 33, FD&C Blue # 1, flavor,
glycerin, high fructose corn syrup, microcrystalline
cellulose and carboxymethylcellulose sodium,
propylene glycol, purified water, sodium benzoate,
sorbitol solution, sucralose, xanthan gum.
Otc - Questions
Questions? Call weekdays from 9:30 AM to 4:30
PM EST at 1-877-798-5944
Principal Display Panel
Premier
Value®
Children's Pain Relief
PAIN RELIEVER· FEVER REDUCER
ACETAMINOPHEN
ORAL SUSPENSION
Grape Flavor
Premier
Value®
Compare to the active
ingredients in Children's
TYLENOL® Oral Suspension**
Ages 2 - 11 years
Children's Pain Relief
PAIN REDUCER - FEVER REDUCER
ACETAMINOPHEN
ORAL SUSPENSION
160 mg per 5 mL
• Alcohol Free
• Aspirin Free
• Ibuprofen Free
Use ONLY enclosed
dosage cup
Grape Flavor
4 FL OZ (118 mL)
INDEPENDENTLY TESTED
PV
SATISFACTION GUARANTEED
DO NOT USE IF PRINTED NECK BAND IS
BROKEN OR MISSING
If for any reason you are not satisfied with this product, please
return It to the store where purchased for a full refund.
DISTRIBUTED BY: PHARMACY VALUE ALLIANCE, LLC
407 EAST LANCASTER AVENUE, WAYNE PA 19087
**This product is not manufactured or distributed by
McNeil Consumer Healthcare, distributor of Children's
Tylenol® Oral Suspension.
BX-073
15
711198
10/17
PRODUCT LABEL
Premier Value Children's Pain Relief Oral Suspension Grape Flavor
end res
* Please review the disclaimer below.